MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

Catalog Number SECX-10-60-135

Device Problem Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician used a protégé stent with a spider fx embolic protection device during a carotid artery stenting procedure.It reported at the end of the procedure post stent deployment, the physician attempted to advance the dual end catheter in order to remove spider fx but the catheter could not be advanced resulting in the spider fx being unable to be removed.The physician then realised that the protégé stent was observed to be curved inwards resulting in less space for the catheter to be passed through.The procedure was converted to open surgery and the spider fx successfully removed from the vessel distal from the stent placed.The patient has recovered, and there was no adverse outcome for the patient.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7840850
• MDR Text Key: 119022141
• Report Number: 2183870-2018-00427
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 00821684038680
• UDI-Public: 00821684038680
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2020
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: A623117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• Date Device Manufactured: 04/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention